Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Study Denileukin Diftitox Followed by Active Immunotherapy Comprising Autologous Dendritic Cells Infected With Recombinant Fowlpox-CEA(6D)-TRICOM Vaccine in Patients With Metastatic CEA-Expressing Malignancies

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	DUMC-NCI-7042 7042, NCI-7042, NCT00128622

Trial Description

Purpose:

Combinations of biological substances in denileukin diftitox may be able to carry cancer -killing substances directly to the cancer cells. Vaccines made from a gene-modified virus and a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving denileukin diftitox together with vaccine therapy may kill more cancer cells.

This phase I trial is studying the side effects of giving denileukin diftitox together with vaccine therapy in treating patients with metastatic cancer that expresses carcinoembryonic antigen.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable or evaluable disease
• At least 4 weeks since biological therapy, chemotherapy, hormone therapy, or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients' white blood cells will be collected and treated in the laboratory to make the vaccine. Patients will be assigned to one of two treatment groups.

Patients in group one will receive an infusion of denileukin diftitox once in week 0. They will also receive an injection of vaccine once in weeks 0, 3, 6, and 9.

Patients in group two will receive an infusion of denileukin diftitox and an injection of vaccine once in weeks 0, 3, 6, and 9.

After finishing treatment, patients will be evaluated once a year for up to 15 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Duke Comprehensive Cancer Center

Michael Morse, MD, Protocol chair		Ph: 919-681-3480

Registry Information
Official Title		A Phase I Study of Regulatory T Cell Depletion with Denileukin Diftitox Followed by Active Immunotherapy with Autologous Dendritic Cells Infected with CEA-6D Expressing Fowlpox-Tricom in Patients with Advanced or Metastatic Malignancies Expressing CEA
Trial Start Date		2005-09-08
Trial Completion Date		2006-03-07 (estimated)
Registered in ClinicalTrials.gov		NCT00128622
Date Submitted to PDQ		2005-06-15
Information Last Verified		2008-04-02
NCI Grant/Contract Number		CA14236, CA117126

Back to Top